Quality Assurance Specialist 100%
vor 1 Woche
Accountabilities
- Ensure qualification of corporate suppliers and subcontractors (API/ IP suppliers, Contract Manufacturers, service providers, etc.)
- Performance of audits
- Establishment of Quality and technical agreements (writing and implementation)
- Execute of quality risk assessment process in a timely manner
- Ensure adherence of suppliers and contract manufacturers to corporate policies/procedures, regulatory MAs, applicable Quality and Technical agreements and applicable US and EU regulations such as those of Pharmaceuticals, Food Supplements and medical devices.
- Provide quality oversight of day to day operations performed at API/ IP suppliers and Contract Manufacturers organization (CMO).
- Review and approval of GMP documentation (CMO Master Batch Records, CMO process validation protocols and reports, CMO stability studies protocols and reports, etc.).
- Review of CMO batch documentation for Stragen or customer release.
- Review and approval of change requests.
- Review and approval of PQRs.
- Management of deviations: Perform and document investigations according to internal procedures
- Management of complaints: Perform and document investigations according to internal procedures
- Management of CAPA: Establish and implement corrective and preventive actions according to internal procedures
- Management of product changeover: Perform, document and coordinate the implementation of change controls
- Management of Quality Risk Assessment : evaluate, control, communicate and review the risk according to internal procedures
- Execute alert and batch recall process
- Provide status reports, including relevant metrics, to HOD QA Operations; actively contributing to QA Operations department and Stragen goals and objectives
- Represents and act as QA Operational in the Product Launch team
- Represent Stragen Quality Assurance including face to face visits, internal/external audits, and Quality Review Meetings
- Support Quality Operations in internal/external audits and regulatory inspections.
- Provide support to customers for QA Operations topics
- Manage own time to carry out assigned duties that support business goals.
- Works as a resource to identify process issues and execute implementation of CAPA in a timely manner to ensure customer commitments are met
- Perform all other duties assigned by the Head of Department / the management
Personal core competencies
- Creativity in problem solving skills
- Good negotiation skills with customer-oriented attitude
- Excellent organizational skills
- Able to prioritize, assess urgency and set deadlines
- Able to manage multiple tasks simultaneously
- Able to establish collaborative relationships
- Able to demonstrate independence, objectivity and ethics
- Able to apply good judgement and good appreciation of quality issues
- Able to work under pressure
- Attentive to details
Skills
- Fluent in English, both written and spoken
- Knowledge of quality management standards / regulations
- Scientific background
- Solid knowledge of GMP and GDP
Qualifications / Prerequisites
- Scientific university degree
- At least 5 years of experience in a Quality Assurance department of a pharmaceutical company
- Experience working in close collaboration with customers & subcontractors
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